Back Pain and Sciatica

Product NDC
50845-0237
11-digit product format
508450237
Labeler code
50845
Product ID
50845-0237_d340d01b-3f0f-4863-a0b0-94cff53d2215
Type
HUMAN OTC DRUG
Nonproprietary name
Aconitum Napellus, Arnica Montana, Belladonna, Cimicifuga Racemosa, Euphorbium Officinarum, Gelsemium Sempervirens, Gnaphalium Polycephalum, Hypericum Perforatum, Magnesia Phosphorica, Phytolacca Decandra, Ranunculus Bulbosus, Rhus Tox
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-01-30
Substance
ACONITUM NAPELLUS WHOLE; ARNICA MONTANA WHOLE; ATROPA BELLADONNA; BLACK COHOSH; EUPHORBIA RESINIFERA RESIN; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM WHOLE; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; PHYTOLACCA AMERICANA ROOT; PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE; RANUNCULUS BULBOSUS WHOLE; TOXICODENDRON PUBESCENS LEAF
Active strength
200; 200; 6; 6; 6; 6; 200; 10; 4; 30; 30; 200 [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50845-0237-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50845-0237-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50845-0237-11332a3947898…d4bfe170f9cd…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50845-0237-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50845-0237-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50845-0237-18dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

Finished product
Yes
Brand name base
Back Pain and Sciatica
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACONITUM NAPELLUS WHOLE200 [hp_C]/mL
ARNICA MONTANA WHOLE200 [hp_C]/mL
ATROPA BELLADONNA6 [hp_X]/mL
BLACK COHOSH6 [hp_X]/mL
EUPHORBIA RESINIFERA RESIN6 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]/mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE200 [hp_C]/mL
HYPERICUM PERFORATUM WHOLE10 [hp_X]/mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE4 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT30 [hp_X]/mL
RANUNCULUS BULBOSUS WHOLE30 [hp_C]/mL
TOXICODENDRON PUBESCENS LEAF200 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U0NQ8555JDInternal UNII lookup
O80TY208ZWInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
K73E24S6X9Internal UNII lookup
1TI1O9028KInternal UNII lookup
639KR60Q1QInternal UNII lookup
36XQ854NWWInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
HF539G9L3QInternal UNII lookup
11E6VI8VEGInternal UNII lookup
AEQ8NXJ0MBInternal UNII lookup
6IO182RP7AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ae11146-b869-4a53-afa3-805de12921f9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-07-01DRUG FACTS:
2024-01-30DRUG FACTS:
2022-04-19DRUG FACTS:
2021-01-29DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0237-1Back Pain and Sciatica30 mL in 1 BOTTLE, SPRAYSPRAY304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0237BACK PAIN AND SCIATICA (ACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, CIMICIFUGA RACEMOSA, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX) SPRAY [LIDDELL LABORATORIES, INC.]4Current NDC, Legacy NDC, 1 package rows20240702_2ae11146-b869-4a53-afa3-805de12921f9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Back Pain and SciaticaACONITUM NAPELLUS, ARNICA MONTANA, BELLADONNA, CIMICIFUGA RACEMOSA, EUPHORBIUM OFFICINARUM, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, MAGNESIA PHOSPHORICA, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOXLiddell Laboratories, Inc.2ae11146-b869-4a53-afa3-805de12921f92024-07-01WarningsExact identifier
ndc (product): 50845-0237

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0237-15084502370130 mL in 1 BOTTLE, SPRAY (50845-0237-1) 30 ml2019-01-300000-00-00NoNoCurrent